Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono-therapy in Chinese Type 2 Diabetes Mellitus (T2DM) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00908921

Purpose

To investigate the glycosylated hemoglobin (HbA1c) control of Glimepiride (AMARYL) as OAD initiation mono-therapy in type 2 diabetic patients in China.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: GLIMEPIRIDE	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Glimepiride as Oral Anti-Diabetic (OAD) Initiation Mono- Therapy in Chinese Type 2 Diabetes Mellitus (T2DM)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glimepiride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in glycosylated hemoglobin (HbA1c) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting Plasma Glucose (FPG) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
Post Prandial Glucose (PPG) rate [ Time Frame: week 16 ] [ Designated as safety issue: No ]
Percentage of patients achieving HbA1c <7.0 [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Enrollment:	392
Study Start Date:	May 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg. At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg. Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion.	Drug: GLIMEPIRIDE Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)

Arms

Assigned Interventions

Experimental: 1

The treatment period is 16 weeks with 5 visits: at weeks 2, 4, 8, 12, 16. At every visit if Fasting Blood Glucose (FBG) >7.0mmol/L the Glimepiride dosage is increased from 1mg to 2mg or 2mg to 4mg.

At every visit if FBG<3.9mmol/L the Glimepiride dosage is decreased from 4mg to 2mg or 2mg to 1mg.

Patients who have been on 4mg for 4 weeks and FBG>11.0mmol/L at visit, another treatment can be added at the physician's discretion.

Drug: GLIMEPIRIDE

Dosage of 1mg, 2mg and 4mg of AMARYL (Glimepiride)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed T2DM and inadequately controlled with diet and exercise or T2DM diagnosed <6 months and who had not taken oral antidiabetic medication or insulin for >3months.
HbA1C more than 7.5 and less than 11.

Exclusion Criteria:

Fasting plasma glucose of >13.5mmol/L
Type 1 Diabetes Mellitus (T1DM)
Patient with acute illness hospitalized in last 2 months
Patient with active liver disease, impaired renal or hepatic functions
Known hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any other excipients of AMARYL
Pregnant and lactating women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908921

Locations

China
Sanofi-Aventis Administrative Office
Shanghai, China

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Mei Mao

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00908921 History of Changes
Other Study ID Numbers:	GLIME_L_04409
Study First Received:	May 26, 2009
Last Updated:	October 4, 2010
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012